Amabile G, Serradimigni A
Z Kardiol. 1985;74 Suppl 2:48-51.
This study was carried out in association with medical practitioners who were responsible for observing the patients. In a first phase, 58 subjects younger than 70 years with moderate essential hypertension were allotted at random to treatment with either indapamide (2.5 mg per day) or muzolimine (20 mg per day). The double blind-double dummy study lasted for six months and demonstrated that the two drugs were similar in efficacy and tolerance. At the end of this phase 42 patients whose supine diastolic blood pressure fell to below 100 mmHg were selected to continue the trial with 20 mg per day muzolimine in an open long-term study. The survey comprised two periods: the first lasted for six months, the patients being examined every two months, and the second lasted for one year and patients were seen quarterly. However, 8 subjects entered directly into the second period. At each examination standing and supine blood pressure, heart rate and body weight were noted; blood was sampled to allow measurements of serum plasma parameters. Thus 15 patients were treated with muzolimine over two years and 15 over 18 months. Clinically the fall in blood pressure observed initially was maintained throughout the rest of the trial; but 3 patients needed another drug, i.e. central hypotensor (2 cases) and beta-blocker (1 case). Two subjects complained of transitory cramps, but 3 other complications not imputable to the treatment were observed: one myocardial infarction and 2 strokes. Biologically there was no change in mean plasma potassium level, but 3 patients received a potassium supplement.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究是与负责观察患者的医学从业者联合开展的。在第一阶段,58名年龄小于70岁的中度原发性高血压患者被随机分配接受吲达帕胺(每日2.5毫克)或莫唑胺(每日20毫克)治疗。双盲双模拟研究持续了6个月,结果表明这两种药物在疗效和耐受性方面相似。在该阶段结束时,选择42名仰卧位舒张压降至100 mmHg以下的患者继续进行开放的长期研究,使用每日20毫克莫唑胺。该调查包括两个阶段:第一阶段持续6个月,每两个月对患者进行检查,第二阶段持续1年,每季度对患者进行检查。然而,8名受试者直接进入第二阶段。每次检查时都记录站立位和仰卧位血压、心率和体重;采集血样以测量血清血浆参数。因此,15名患者接受莫唑胺治疗两年,15名患者接受治疗18个月。临床上,最初观察到的血压下降在试验的其余阶段得以维持;但有3名患者需要加用另一种药物,即中枢性降压药(2例)和β受体阻滞剂(1例)。两名受试者抱怨有短暂性痉挛,但观察到3例与治疗无关的其他并发症:1例心肌梗死和2例中风。生物学上,血浆钾平均水平没有变化,但有3名患者接受了钾补充剂。(摘要截断于250字)